difluprednate ophthalmic (Rx)

Brand and Other Names:Durezol
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ophthalmic solution

  • 0.05%

Ocular Inflammation & Pain

Initate 24 hours postop: Instill 1 gtt in conjunctival sac of affected eye(s) q6hr for 2 weeks, then q12hr for1 week, then taper and discontinue

Uveitis

Indicated for treatment of endogenous anterior uveiti

Instill 1 ftt into conjunctival sac to affected eye(s) q6hr for 14 days and then taper dose downward as clinically indicated

Safety and efficacy not established

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Adverse Effects

Frequency Not Defined

Increased IOP

Anterior chamber inflammation

Corneal edema

Conjunctival edema

Blepharitis

Cataract

Optic nerve damage

Abnormal healing (after surgery)

Local irritation

Punctate keratitis

Hyperemia

Punctate keratitis

Decreased visual acuity

Eye pain

Photophobia

Postmarketing Reports

Elevated intraocular pressure

Posterior subcapsular cataract formation

Secondary ocular infection

Perforation of the globe

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Warnings

Contraindications

Most active viral diseases of cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures

Cautions

Use caution in glaucoma, prolonged use may increase IOP (monitor)

May increase risk of cataracts

The use of steroids after cataract surgery may delay healing and increase incidence of bleb formation; perforations, associated with thinning of cornea or sclera, may occur; initial prescription and renewal of medication order beyond 28 days should be made by a physician only after examination of patient with aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining

Employment of corticosteroid medication in treatment of patients with history of herpes simplex requires great caution; use of ocular steroids may prolong course and may exacerbate severity of many viral infections of the eye (including herpes simplex)

Prolonged use of corticosteroids may suppress host response and thus increase hazard of secondary ocular infections; in acute purulent conditions, steroids may mask infection or enhance existing infection; if signs and symptoms fail to improve after 2 days, patient should be re-evaluated

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application; fungus invasion must be considered in any persistent corneal ulceration where steroid has been used or is in use

Not for intraocular administration

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk. Use caution.

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Antiinflammatory corticosteroid; inhibits inflammatory response including capillary dilation, edema, leukocyte migration, and scar formation

Absorption

Absorption: Negligible absorption

Metabolism: Undergoes deacetylation to active metabolite

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Durezol ophthalmic (eye)
-
0.05 % drops

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
difluprednate ophthalmic (eye)

DIFLUPREDNATE - OPHTHALMIC

(DYE-floo-PRED-nate)

COMMON BRAND NAME(S): Durezol

USES: This medication is used to treat swelling and pain after eye surgery. It may also be used to treat a certain serious eye problem (endogenous anterior uveitis). This medication belongs to a class of drugs known as corticosteroids.

HOW TO USE: To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.If you are wearing contact lenses, remove them before using eye drops. Wait at least 10 minutes before replacing your contact lenses.Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed or if your dose is for more than 1 drop.Do not rinse the dropper. Replace the dropper cap after each use.Use this medication exactly as directed by your doctor. Your doctor may direct you to use this medication more often at the beginning of treatment and then reduce your dose gradually. Do not stop using this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day. Continue using it for the full time prescribed.If you are using another kind of eye medication (for example, drops or ointments), wait at least 5 to 10 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.Tell your doctor if your condition persists or does not improve.

SIDE EFFECTS: Temporary blurred vision may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Use of this medication for prolonged or repeated periods may result in a new fungal infection. Do not use this medication for longer than prescribed.Tell your doctor right away if any of these unlikely but serious side effects occur: new or increased eye pain/swelling/discharge/redness, eye pain/discomfort in bright light, vision changes.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using difluprednate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: current or past eye infection (including viral infections such as herpes simplex keratitis), cataracts, glaucoma.After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if difluprednate passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as intraocular pressure) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.